Objective:

2

To assess the effectiveness and safety of Biqi Capsules in the treatment of rheumatoid arthritis (RA).

Methods:

2

This multicenter

prospective cohort study was conducted across more than 100 centers in China. Data on RA patients were collected from the CERTAIN database between January 2019 and March 2024. Patients were categorized into an exposed group and a control group. The control group was treated with conventional Western medicine

and the exposed group was combined with Biqi Capsules (0.3 g/capsule

4 capsules per dose

orally

2–3 times/d) on the basis of conventional treatment. Propensity score matching (PSM) was applied to balance baseline characteristics. The main outcomes was the Disease Activity Score-28 (DAS28-ESR)

and secondary outcomes included Health Assessment Questionnaire (HAQ)

Visual Analogue Scale (VAS) for pain

tender joint count (TJC)

swollen joint count (SJC)

Patient Global Assessment (PGA)

and Evaluator Global Assessment (EGA) scores

as well as erythrocyte sedimentation rate (ESR)

and other laboratory test results as safety indicators.

Results:

2

A total of 2

267 patient records were analyzed

with 711 in the exposed group and 1

556 in the control group. After PSM

710 patients were included in each group

with comparable baseline demographic characteristics (

P

>

0.05). Following matching

pre-treatment HAQ and TJC were similar between groups (

P

>

0.05)

while significant differences were observed in DAS28-ESR

EGA

PGA

VAS

SJC

TJC

and ESR (

P

<

0.01). Post-treatment analysis showed that all indices improved significantly in both groups(

P

<

0.01). Furthermore

post-treatment levels of EGA

PGA

VAS

SJC

and TJC were statistically significant between the two groups (

P

<

0.01). The reduction in DAS28-ESR was significantly greater in the exposed group than in the control group (

P

<

0.01). Statistically greater improvements were also found in EGA

PGA

SJC

TJC

and ESR

indicating superior clinical improvement in the exposed group (

P

<

0.01). The incidence of abnormal γ-glutamyl transferase and creatinine levels were higher in the control group than in the exposed group (

P

<

0.01 or

P

<

0.05)

while no significant differences were observed in other safety indicators between the two groups (

P

>

0.05).

Conclusion:

2

Biqi Capsules combined with conventional treatment of Western medicine effectively reduce RA disease activity

lower inflammation levels

relieve clinical symptoms

and do not increase the incidence of adverse events. (Registration No. NCT05219214)